PROCOTYL-E ACETABULAR SYSTEM

{0}------------------------------------------------ K043073 Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in large, bold, black letters. Below the word are three stylized, textured, arrow-like shapes pointing to the left. The arrows are arranged in a descending order, with the top arrow being the largest and the bottom arrow being the smallest. The letters "IV" are visible below the arrows. MAY - 4 2005 ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROCOTYLE-E. Submitted By: Date: Contact Person: Proprietary Name: Common Name: Classification Name and Reference: Wright Medical Technology, Inc. November 5, 2004 Ehab M. Esmail Senior Manager, Regulatory Affairs #### PROCOTYLE-E Acetabular Shell 21 CFR 888.3358 Hip joint metal/polymer/metal semi- constrained porous - coated uncemented prosthesis -- Class II 21 CFR 888.3353 Prosthesis, Hip, Semi-Constrained, metal/ ceramic/ polymer, cemented or non-porous uncemented- Class II 21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with uncemented acetabular component prosthesis -- Class III Device Product Code and Panel Code: Orthopedics/87/LPH, KWA, LZO ### DEVICE INFORMATION ### A. INTENDED USE The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; 2. - correction of functional deformity; 3. - 4. revision procedures where other treatments or devices have failed; and, - treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5. with head involvement that are unmanageable using other techniques. Arlington, TN 38002 011.49.4161.745130 Germany {1}------------------------------------------------ K043073 2/2 The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylenc and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty. ### B. DEVICE DESCRIPTION The PROCOTYL-E Acetabular System consists of metal acetabular shells, plates and hooks. The added design features of the PROCOTYL-E Acetabular Shell are summarized below: - The PROCOTYL-E Acetabular shell feature an oblong dual hemispherical outer . geometry with a hemispherical offset to accommodate for bone loss. - Eccentricity and offset are increased to accommodate for bone loss and screw fixation . - The PROCOTYL-E shell allows use of a wide range of plates, hooks, all of which are . manufactured from titanium alloy, available in various types and sizes, thus guaranteeing a stable and secure anchorage of the shell to enhanced fixation and stability. ### C. SUBSTANTIAL EQUIVALENCE INFORMATION The intended use, material, type of interface, and design features of the PROCOTYL-E Acetabular Shell are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the PROCOTYL-E Acetabular Shell are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY - 4 2005 Mr. Ehab M. Esmail Senior Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002 Re: K043073 Trade/Device Name: PROCOTYL-E Acetabular System Regulation Numbers: 21 CFR 888.3330, 888.3353, 888.3358 Regulation Names: Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: III Product Codes: KWA, LZO, LPH Dated: March 25, 2005 Received: March 28, 2005 Dear Mr. Esmail: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ # Page 2 – Mr. Ehab M. Esmail Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr is issuaires or our device complies with other requirements of the Act that FDA has made a dolorimiation administered by other Federal agencies. You must of ally redital statutes and regarations and limited to: registration and listing (21 Comply with an the rive orequentions)01); good manufacturing practice requirements as set CFK Fart 807), labeling (21 OF R Part 820); and if applicable, the electronic form in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manesing your device of your device to a legally premits that notication. The President for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific aarroliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Company of Company of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sincerery yours, Stpt Rlurde riam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic of three stylized, overlapping shapes that resemble wings or chevrons. The "TM" symbol is located at the bottom right of the graphic. ### PROCOTYL-E Acetabular System INDICATIONS STATEMENT 1043073 510(k) Number (if known): #### Device Name: PROCOTYL-E Acetabular System Indications For Use: The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; 2. - correction of functional deformity; 3. - revision procedures where other treatments or devices have failed; and, 4- - treatment of fractures that are unmanageable using other techniques. న్. The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acctabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrent (Division Sign-Off)vice Evaluation (ODE) | | | | |-----------------------------------------------------|--|--|--| | Division of General, Restorative, | | | | | and Neurological Devices | | | | | headquarters<br>Wright Medical Technology, Inc. 5677 Airline Road | 510(k) Number | K043073 | |-------------------------------------------------------------------|--------------------|-------------| | Arlington, TN 38002 | 901.867.9971 phone | www.wmt.com | | international subsidiaries | | | | |----------------------------|--------------------------|-----------------------------|----------------------------| | 011.32.2.378.3905 Belgium | 905.826.1600 Canada | 011.33.1.45.13.24.40 France | 011.49.4161.745130 Germany | | 011.39.0250.678.227 Italy | 011.81.3.3538.0474 Japan | 011.44.1483.721.404 UK | |